Given the effects generated by the coronavirus at a global level, the world hopes to have a vaccine that can protect us. That is why multiple studies are being carried out to verify the efficacy of the vaccine and to implement an immunization plan to contain Covid – 19.
Colombia participates in clinical trials to find a vaccine, and volunteers who want to participate are received at the Hospital Universidad del Norte to advance a definitive, safe and effective solution against the coronavirus.
We collect the most frequently asked questions for those who decide to participate as volunteers:
1. What is a clinical trial?
A clinical trial is a scientific evaluation of a vaccine or medicine, which has different phases of testing in humans to verify its safety and efficacy. Thanks to clinical trials and the people who participate in them, Currently there are effective drugs and vaccines for the treatment of various diseases.
2. Why are volunteers required for clinical trials?
Historically, the development of vaccines and other drugs has been tested in humans, who act as volunteers to help humanity and improve the quality of life of people suffering from diseases. Volunteers are healthy people or patients who suffer from diseases and thanks to their participation it is possible to verify the efficacy and safety of medicines. In the case of the Covid -19 vaccine, people over 60 years of age are especially needed.
3. To participate in the COVID-19 vaccine clinical trial, do I have to have or have had COVID-19?
People who currently have Covid-19 cannot participate. They can participate after having had covid or never having contracted the infection.
4. Are the vaccines in the clinical trial safe?
The study is designed to minimize the occurrence of side effects and will be closely monitored, Certain side effects (for example, soreness at the vaccination site, low-grade fever, muscle or body pain) usually go away within a day or two without limiting your usual activities or requiring any kind of medical attention. Before the registration of the participants, an ethics committee made up of doctors, lawyers and representatives of the community review that the study is safe for the people who are going to participate and make sure that the doctors who carry out these studies comply with standards strict to protect participants as much as possible.
5. Are there any adverse events or risks to my health if I participate in the trial?
The most frequent side effects are pain at the application site, headache, general malaise, dizziness, fever, among other adverse events of vaccines in general.
6. Is it possible to get COVID-19 from the vaccine being tested on my body?
No. The experimental vaccine generates immunity that helps protect the body.
7. What happens if during the clinical trial of the vaccine in my body I get COVID-19?
You must notify the Research Center who will apply the test for the diagnosis of COVID-19, as well as surveillance and medical monitoring during the disease.
8. Can I continue with my normal activities after vaccination or are there any restrictions?
There is no restriction. You can continue with your daily routine, following normal self-care measures: wearing a mask, hand washing, and personal distance.
9. Can I participate in the clinical trial if I have type 1 or 2 diabetes, hypertension, obesity, asthma, a cardiovascular complication, or comorbidity associated with COVID-19?
Yes. The study includes volunteers older than 18 years, especially the population older than 60 years with or without these diseases.
10. Can I withdraw from the clinical trial whenever I want?
Participation in a clinical trial is completely voluntary. If you decide to participate, you can withdraw at any time.
11. Will there be compensation for participants in the COVID-19 vaccine clinical study?
Participants will receive medical care related to the study and compensation for expenses to and from the research center, but will not be paid for other types of medical care or medications that are part of their usual medical care. The process is voluntary, which does not imply financial remuneration.
12. What should I do to apply as a volunteer?
Enter your details in www.hospitaluniversidaddelnorte.com to be contacted by the HUN Research Center team.